Skip to main content
OpenTrials
Completed

NCT Number: NCT03764462

Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, 41944, South Korea

About this study

This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Adult aged 19 and more at the time of screening visit
  • Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
  • No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination

Exclusion criteria

  • Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
  • History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
  • As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range

Treatment and study plan

AD-101 45mg

Drug

Raloxifene 45mg tablet

Other names: AD-101

Raloxifene 60mg

Drug

Raloxifene 60mg tablet

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: pre-dose to 96 hours

    Cmax of the total ingredient of AD-101

  2. Area under the curve in time plot (AUCt)

    Time frame: pre-dose to 96 hours

    AUCt of the total ingredient of AD-101

Secondary outcomes

  1. Area under the curve in time plot (AUCinf)

    Time frame: pre-dose to 96 hours

    AUCinf of the total ingredient of AD-101

  2. Time to reach Cmax

    Time frame: pre-dose to 96 hours

    Tmax of the total ingredient of AD-101

  3. Effective half-life

    Time frame: pre-dose to 96 hours

    t1/2 of the total ingredient of AD-101

  4. Clearance

    Time frame: pre-dose to 96 hours

    CL/F of the total ingredient of AD-101

  5. Volume of distribution

    Time frame: pre-dose to 96 hours

    Vd/F of the total ingredient of AD-101

Other outcomes

  1. Number of participants with adverse events

    Time frame: From Day 1 until 40 Days

    Incidence rate of adverse events

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2018
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.